Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Sponsors

Lead sponsor: Baxalta now part of Shire

Source Shire
Brief Summary

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.

Overall Status Completed
Start Date January 1, 2003
Completion Date December 1, 2003
Primary Completion Date December 1, 2003
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Subjects Who Qualify As Treatment Responders Baseline thru Day 15 post treatment
Secondary Outcome
Measure Time Frame
Time to achieve a platelet count > 50 x 109/L
duration of Duration of platelet response
Maximum Platelet Count
Safety In Terms Of Adverse Experiences
Enrollment 28
Condition
Intervention

Intervention type: Drug

Intervention name: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution

Eligibility

Criteria:

Inclusion Criteria:

- Age >= 18 and <= 65 years

- ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear

- Baseline platelet count of <= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion

- No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug

- For females of child bearing potential, use of adequate birth control measures during study participation

- Written informed consent

Exclusion Criteria:

- Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening

- Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening

- Underlying other autoimmune or lymphoproliferative disorder

- Uncontrolled hypertension

- Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV

- Malignancy or history of malignancy

- Documented selective IgA deficiency (<= 10 mg/dL)

- Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product

- History of severe adverse reactions to blood and/or blood products

- Pregnancy or lactation

- Positivity for HIV, or HCV antibodies, or HBsAg

- History of unresponsiveness to IVIG defined as a peak increment in platelet count <= 20,000/µL coincident with the last IVIG treatment course prior to study entry

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Baxter BioScience Investigator Principal Investigator Baxter BioScience
Location
facility
| Brno, Czechia
| Hradec Králové, Czechia
| Olomouc, Czechia
| Prague, Czechia
| Giessen, Germany
| Halle/Saale, Germany
| Debrecen, Hungary
| Györ, Hungary
| Szeged, Hungary
| Szombathely, Hungary
| Lodz, Poland
Location Countries

Czechia

Germany

Hungary

Poland

Verification Date

January 2018

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov